Pharmaceutical packaging: Aptar Pharma’s dispenser gains safety approval

31 Jul 2018 --- Aptar Pharma, part of the AptarGroup who globally supply dispensing and sealing solutions, has made strides in the packaging for pharmaceutical space with its Ophthalmic Squeeze Dispenser being approved by the French National Agency of Medicines and Health Products Safety (ANSM). The Ophthalmic Squeeze Dispenser is also the first and only FDA-reviewed delivery system for multidose, preservative-free Eye Care products, reports the company.

“Our Ophthalmic Dispenser technology has been a great success for our customers,” says Matthias Birkhoff, Vice President Business Development, Aptar Pharma. “The proven and unrivaled microbiological safety, combined with a precise and reproducible drop ejection, allows pharmaceutical customers worldwide to enter into discussions with regulatory agencies such as the French ANSM with confidence.”

This approval further expands the regulatory acceptance of Aptar Pharma’s Ophthalmic Squeeze Dispenser as an approved delivery system for preservative-free Eye Care formulations.

When developing novel Eye Care products, pharmaceutical companies need to deliver improved patient safety, accurate dosing and product integrity. Aptar Pharma’s Ophthalmic Squeeze Dispenser meets these key industry and patient needs, the company reports.

Aptar Pharma has been working closely with Bausch and Lomb, an eye care company, to achieve this first ANSM approval of an Eye Care product in its multidose device. The device is now the approved delivery service for Bausch and Lomb’s Levofree Multidose product, a prescription product for the treatment of allergic conjunctivitis. 

Packaging for pharmaceuticals
Packaging for pharmaceuticals poses particular difficulties for manufactures as the space is highly regulated.

The ANSM approval culminates a long and robust process, the company state. Prior to approval, Bausch and Lomb provided comprehensive, detailed microbiological study results which showed that microorganisms can neither survive nor form colonies in or on the container. In addition, user studies were performed that confirmed the user-friendliness of the multi-dose device within the patient target group.

Thereby, Aptar Pharma’s Ophthalmic Squeeze Dispenser system is the result of more than ten years of development and experience in the delivery of preservative-free ophthalmic solutions.

Further challenges in the packaging for pharmaceuticals space, beyond sterilization and regulations, includes serialization and sustainable packaging.

Aptar Pharma is part of the AptarGroup family of companies, along with Aptar Beauty, Home and Aptar Food and Beverage. It creates innovative drug delivery systems that are said to meet the evolving needs of biotechnology, healthcare and pharmaceutical companies around the world.

PackagingInsights has previously reported on the launch of a new tube-style pharmaceutical packaging which was the result of a collaboration between Schreiner MediPharm and Neopac. The label design encloses the tube like a pocket and can be automatically dispensed on packaging lines, offering an alternative to glass tubes.